Commissioning and qualification engineer

Commissioning and Qualification Engineer

We're currently recruiting for an exciting opportunity with a leading biopharmaceutical organization based in Cork.

This is an excellent position for anyone who is looking to join a multinational that excels in their field.


Duties

1. Coordinates and supervises all commissioning and qualification activities.
2. Generates commissioning and qualification planning documents detailing the overall strategy for the project.
3. Develops the master list of commissioning and qualification test documents and activities.
4. Generates all commissioning and qualification summary reports.
5. Ensures the commissioning and qualification schedule is developed and maintained.
6. Generates all commissioning and qualification test documents, including plans, set-to-work instructions, factory acceptance tests, site acceptance tests, installation qualification, operational qualification, and functional testing.
7. Responsible for tracking and reporting on the status and risks/issues related to commissioning and qualification.
8. Ensures the safe and coordinated startup of equipment and utilities.
9. Assists in the development of user requirement specifications and quality documentation.


Education & Experience

1. Requires 6+ years of experience in engineering or commissioning and qualification management.
2. Technical qualification at third level or equivalent in engineering.
3. Extensive knowledge and demonstrated experience managing commissioning and qualification for pharmaceutical and biotechnology projects.
4. Experience with sterile and biotech equipment within the pharmaceutical industry is preferred.
5. Knowledge of safety, good manufacturing practice (GMP), and environmental regulatory requirements.